- Labeler Index
- Nephron Pharmaceuticals Corporation
- FDA Recalls NDC: 0487-9501 Albuterol Sulfate
FDA Recalls Enforcement Reports
The last Recall Enforcement Report for Albuterol Sulfate with NDC 0487-9501 was initiated on 04-13-2022 as a Class II recall due to cgmp deviations: temperature abuse The latest recall number for this product is D-1020-2022 and the recall is currently ongoing .
|Recall Number||Initiation Date||Report Date||Recall Classification||Product Quantity||Product Description||Status|
|D-1020-2022||04-13-2022||06-15-2022||Class II||96 pouches||Albuterol Sulfate Inhalation Solution 0.083%, 2.5 mg/3mL, packaged in 25 X 3mL unit-dose vials, Rx only, MFG by: Nephron Pharma, NDC 0487-9501-25||Ongoing|
|D-1019-2022||04-13-2022||06-15-2022||Class II||23 pouches||Albuterol Sulfate Inhalation Solution 0.083%, 2.5 mg/3mL, packaged in 5 x 3 mL unit-dose vials, Rx only, Manufactured by: Nephron Pharma, NDC 0487-9501-03||Ongoing|
|D-66462-001||10-02-2013||10-30-2013||Class II||689,568 cartons||Albuterol Sulfate Inhalation Solution, 0.083% 2.5 mg/3 mL for Oral Inhalation Only, Rx Only, 25 x 3 mL Sterile Unit-Dose Vials per carton, Manufactured By: Nephron Pharmaceuticals Corporation, Orlando, FL 32811, NDC 0487-9501-25||Terminated|
|D-1446-2012||06-22-2011||08-15-2012||Class II||56,028 cartons||Albuterol Sulfate Inhalation Solution, 0.083%, 2.5 mg/3 mL Sterile Unit-Dose Vials, 60-count (60 x 3 mL Sterile Unit-Dose Vials) per carton, Rx only, Manufactured by: nephron pharmaceuticals corporation, Orlando, FL 32811, NDC 0487-9501-60.||Terminated|
What is the Enforcement Report?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.